USA – Draft FDA guidance addresses oncology drug cross labeling

In response to increasing requests from sponsors applying for oncology drugs intended to be used in combination regimens, the US Food and Drug Administration has released draft guidance for how oncology drugs used in combination regimens can be referenced by means of cross-labeling.

« Oncology drug applications to the FDA often add investigational drugs to current regimens to create new combination regimens with greater efficacy or safety,” said Richard Pazdur, MD, director of FDA’s Center of Oncology Excellence and acting director of the Office of Oncologic Diseases in the Center for Drug Evaluation and Research.

In a press statement, Pazdur added, “Sponsors have traditionally not requested cross-labeling—making changes to the labeling of a previously approved drug that describes how to use that drug in a new regimen.” Increasingly, though, Pazdur said that applications are proposing cross-labeling for combinations of drugs to treat cancer…